check_circleStudy Completed
Prostate Cancer, Ovarian Cancer
Bayer Identifier:
91695
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Prevention of Sagopilone-induced neurotoxicity with Acetyl-L-Carnitine (ALC)
Trial purpose
This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.
Key Participants Requirements
Sex
BothAge
18 - 70 YearsTrial summary
Enrollment Goal
150Trial Dates
August 2008 - August 2010Phase
Phase 2Could I Receive a placebo
NoProducts
Sagopilone (BAY86-5302)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum der Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Klinikum Südstadt | Rostock, 18059, Germany |
Completed | Centre René Gauducheau | Nantes, 44805, France |
Completed | Centre René Gauducheau - Nantes | NANTES, 44805, France |
Completed | Diaconesses Croix Saint Simon - Paris | Paris, 75012, France |
Completed | Centre Val d'Aurelle - Montpellier | MONTPELLIER CEDEX, 34298, France |
Completed | IRST Istituto Scientifico Romagnolo per studio e cura Tumori | Meldola, 47014, Italy |
Completed | AUSL Rimini - Emilia Romagna | Rimini, 47900, Italy |
Completed | Academisch Ziekenhuis Maastricht | Maastricht, 6229 HX, Netherlands |
Completed | Vrije Universiteit Medisch Centrum | AMSTERDAM, 1081 HV, Netherlands |
Completed | Universitätsklinikum Essen | Essen, 45147, Germany |
Completed | Otto-von-Guericke-Universität Magdeburg | Magdeburg, 38108, Germany |
Completed | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Completed | Mount Vernon Hospital | Northwood, HA6 2RN, United Kingdom |
Completed | Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom |
Completed | Centre Francois Baclesse | Caen, 14076, France |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Completed | A.O.U. di Bologna | Bologna, 40138, Italy |
Completed | A.O. Sant'Andrea | Roma, 00189, Italy |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Nederlands Kanker Instituut | Amsterdam, 1066 CX, Netherlands |
Completed | Leids Universitair Medisch Centrum | Leiden, 2333 ZA, Netherlands |
Primary Outcome
- Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.date_rangeTime Frame:Start of Sagopilone treatment until at most 6 cycles + 1 month.enhanced_encryptionyesSafety Issue:
Secondary Outcome
- Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.date_rangeTime Frame:Start of treatment to safety Follow-upenhanced_encryptionyesSafety Issue:
- Efficacy of ALC: Percentage of discontinuations due to neuropathy.date_rangeTime Frame:Start of treatment to safety Follow-upenhanced_encryptionnoSafety Issue:
- Safety of Sagopilone in combination with ALC.date_rangeTime Frame:Baseline to Safety follow-upenhanced_encryptionyesSafety Issue:
- Efficacy of Sagopilone: 'best overall response' according to modRECIST criteriadate_rangeTime Frame:Start treatment to End of Treatmentenhanced_encryptionnoSafety Issue:
- Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA responsedate_rangeTime Frame:Start treatment to End of Treatmentenhanced_encryptionnoSafety Issue:
- Efficacy of Sagopilone: Time to disease progression, Progression-free survivaldate_rangeTime Frame:Start treatment to Progression or Deathenhanced_encryptionnoSafety Issue:
- Efficacy of Sagopilone: Duration of responsedate_rangeTime Frame:Start treatment to Progression or Deathenhanced_encryptionnoSafety Issue:
- Efficacy of Sagopilone: WHO performance status.date_rangeTime Frame:Screening to end of Treatmentenhanced_encryptionnoSafety Issue:
- Pharmacokinetic: Sagopilone concentrations (optional)date_rangeTime Frame:Day 1,2,3,5,15 of cycle 1 and day2enhanced_encryptionnoSafety Issue:
- Pharmacokinetic: ALC concentrationsdate_rangeTime Frame:radomisation, day 1 of cycle 1 and 2enhanced_encryptionnoSafety Issue:
- Pharmacogenomics (optional): in tumor tissue, blood and ascitesdate_rangeTime Frame:Blood sample at screening, tissue sample and ascites whenever availableenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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